Brief Title
Community Outreach for Palliative Engagement -- Parkinson Disease
Official Title
Building Online Community to Improve Patient and Caregiver Outcomes in Parkinson Disease, Lewy Body Dementia and Related Disorders
Brief Summary
The purpose of this study is to learn more about the effectiveness of palliative care training for community physicians and telemedicine support services for patients and carepartners with Parkinson's disease and Lewy Body Dementia (LBD) or related conditions and their care partners. Palliative care is a treatment approach focused on improving quality of life by relieving suffering in the areas of physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Telemedicine is the use of technology that allows participants to interact with a health care provider without being physically near the provider.
Detailed Description
Investigators propose to conduct a pragmatic stepped-wedge comparative effectiveness trial comparing a novel model of providing community-based palliative care for persons living with Parkinson's disease (PD), Lewy Body Dementia (LBD) and related disorders through online communities to usual care. Our intervention includes support for both community neurologists (using the ECHO model of clinician support) as well as family caregivers and patients. Investigators hypothesize that this model of care will improve patient quality of life and caregiver burden as well as other important secondary outcomes such as patient symptom burden and clinician burnout. This study will recruit neurology providers (MD and APPs) from 24 community neurology practices. These practices will identify participants for the study who have PD, LBD or a related condition and moderate to high palliative care needs. Under usual care, community providers will deliver their usual care and center coordinators will collect data on our outcomes every 3 months. After one year of baseline data collection, 6 practices will be randomized to the intervention, which will include clinician training and coaching as well as access to online services for their patients. Per the stepped-wedge design an additional six practices will be randomized 18 months into the data collection period, six at 24 months, and the final six will enter the intervention 30 months into the data collection period to allow for 12 months intervention recruitment for all practices.
Study Type
Interventional
Primary Outcome
Quality of Life: Alzheimer's Disease (QOL-AD)
Secondary Outcome
Patient Measures Edmonton Symptom Assessment Scale
Condition
Parkinson Disease Dementia
Intervention
Parkinson Disease Standard Care
Study Arms / Comparison Groups
Usual Care
Description: Community neurologists provide their usual care to enrolled participants. The clinicians may utilize other community resources to support patients and families as per their usual practice.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
710
Start Date
April 26, 2022
Completion Date
August 31, 2026
Primary Completion Date
February 28, 2026
Eligibility Criteria
Inclusion Criteria: PATIENT INCLUSION CRITERIA: • Over age 40 years and diagnosed with PD or other causes of parkinsonism, such as progressive supranuclear palsy, multiple system atrophy and Lewy Body Dementia by their community neurologist. Exclusion Criteria: PATIENT EXCLUSION CRITERIA: - Potential patient subjects who are unable or unwilling to commit to study procedures - Presence of additional medical illnesses which requires palliative services (e.g. metastatic cancer) - Already receiving palliative care or hospice services.
Gender
All
Ages
40 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Benzi Kluger, MD, 585-275-2529, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05222386
Organization ID
STUDY6775
Responsible Party
Principal Investigator
Study Sponsor
University of Rochester
Collaborators
University of Colorado, Denver
Study Sponsor
Benzi Kluger, MD, Principal Investigator, University of Rochester
Verification Date
May 2022